ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet 
Aurohealth LLC

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

•    temporarily relieves minor aches and pains due to:

    •    the common cold

    •    headache

    •    backache

    •    minor pain of arthritis

    •    toothache

    •    muscular aches

    •    premenstrual and menstrual cramps

•    temporarily reduces fever

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take

Allergy alert:acetaminophen may cause severe skin reactions.

Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor

Other information

Inactive ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC.
279 Princeton- Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

NDC 58602-776-88Primary Health

Compare to the active ingredient in
Tylenol ® Extra strength Caplets *
 

See New Warnings Information & Directions

EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen Caplets 500 mg
Pain reliever/Fever reducer
N 79

750 CAPLETS
500 mg each
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

ACETAMINOPHEN EXTRA STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-776
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
Product Characteristics
Colorwhite (White to off White) Scoreno score
ShapeCAPSULE (Biconvex) Size18mm
FlavorImprint Code N79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-776-88750 in 1 BOTTLE; Type 0: Not a Combination Product09/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/02/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777analysis(58602-776) , manufacture(58602-776)

Revised: 11/2023
Document Id: 0b4541a6-ce74-d7e6-e063-6294a90aa709
Set id: 57bb1acc-b9a0-48cd-8e5c-33712441ce81
Version: 2
Effective Time: 20231129
 
Aurohealth LLC